FDA ANDA · ANDA077559

IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE

Sponsor: CIPLA

APPLICATION

ANDA077559

TYPE

ANDA

ORIGINAL APPROVAL

2007-12-31

LATEST ACTION

2016-03-24

ROUTE

RESPIRATORY (INHALATION), INHALATION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEPrescription

ALBUTEROL SULFATE EQ 0.083% BASE, IPRATROPIUM BROMIDE 0.017% · SOLUTION · INHALATION

2016-03-24Labeling · Supplement 5 · standardAP

2013-01-31Labeling · Supplement 4 · standardAP

2007-12-31OriginalAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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